Pericardial Stentless Valve for Aortic Valve Replacement: Long-Term Results.
Pericardial Stentless Valve for Aortic Valve Replacement: Long-Term Results.
复制标题
用于主动脉瓣置换术的心包无支架瓣膜：长期结果。
DOI：
10.1016/j.athoracsur.2016.05.080
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发表时间：
2016
期刊：
影响因子：
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通讯作者：
H. Grubitzsch
中科院分区：
文献类型：
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作者：
A. Repossini;T. Fischlein;G. Santarpino;C. Schäfer;B. Claus;B. Passaretti;L. Di Bacco;L. Giroletti;G. Bisleri;C. Muneretto;H. Grubitzsch
Free Solo(FS)牛心包瓣膜(Sorin Group，米兰，意大利)是一种无支架生物假体，于2004年推出，并于2014年获得美国食品和药物管理局(FDA)的批准。到目前为止，还没有长期的后续系列研究。从2004年到2009年，565例患者(242例女性，42.8%；平均年龄74.6±8.3岁)接受了单独(350例)或联合(215例)联合应用FS的主动脉瓣置换术。包括临床和严格的超声心动图评估在内的平均随访时间为6.9±3.7年(最长为11.8年；累计为2965人年)。主要终点是避免瓣膜结构恶化(SVD)，次要终点是免于再次手术和总体生存。结果欧洲心脏手术风险评估系统的平均值为10.3%±6.7%。总的30天死亡率为3.7%，没有与瓣膜相关的死亡。没有严重的假体-患者不匹配，中度假体-患者不匹配只有1例(0.17%)。28例(5.2%)因心内膜炎再次手术(20例外科手术，8例经导管主动脉瓣置换术)，1例钝性损伤，18例SVD。随访10年，置换率为90.8%(95%可信区间，89.1%~92.5%)和87.3%(95%可信区间，85.6%~89.0%)，总的精算存活率为56.4%(95%可信区间，53.3%~59.5%)。此外，FS由于SVD发生率低，且可植入性简单，被证明是一种可靠的主动脉位置生物假体，是一种有效的支架生物假体替代方案。
BackgroundThe Freedom Solo (FS) bovine pericardial valve (Sorin Group, Milan, Italy) is a stentless bioprosthesis that was introduced in 2004 and approved by the United States Food and Drug Administration in 2014. No long-term follow-up series are available to date. We report the multicenter experience of 4 European institutions that began implanting FS extensively from its introduction, providing the largest series with long-term follow-up.MethodsFrom 2004 to 2009, 565 patients (242 women [42.8%]; mean age, 74.6 ± 8.3 years) underwent isolated (n = 350) or combined (n = 215) aortic valve replacement with the FS. Mean follow-up, including clinical and strict echocardiographic evaluation, was 6.9 ± 3.7 years (maximum, 11.8 years; cumulative 2,965 patient-years). Primary end point was freedom from structural valve deterioration (SVD), and secondary end points were freedom from reoperation and overall survival.ResultsMean logistic European System for Cardiac Operative Risk Evaluation I was 10.3% ± 6.7%. Overall 30-day mortality was 3.7%, and no deaths were valve related. There was no severe prostheses-patient mismatch, and moderate prostheses-patient mismatch occurred only in 1 patient (0.17%). Twenty-eight patients (5.2%) underwent reoperation (20 surgical replacements, 8 transcatheter aortic valve-in-valve replacements) due to endocarditis in 9, blunt trauma in 1, and SVD in 18. SVD was reported in 5 other patients alive at time of censoring. Freedom from SVD and reoperation was 90.8% (95% confidence interval, 89.1% to 92.5%) and 87.3% (95% confidence interval, 85.6% to 89.0%), respectively, at 10 years of follow-up, and the overall actuarial survival was 56.4% (95% confidence interval, 53.3% to 59.5%).ConclusionsThe FS valve provided excellent long-term durability and hemodynamic performance in this large, multicenter European experience. Moreover, the FS, given the low rate of SVD, along with a simple implantability, proved to be a reliable bioprosthesis in the aortic position as a valid alternative to stented bioprostheses.